primary batch
- Guideline or reference source
- ICHQ1A Stability testing of new drug substances and drug products
- Definition
- A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a re-test period or shelf life, respectively. A primary batch of a drug substance should be at least a pilot scale batch. For a drug product, two of the three batches should be at least pilot scale batch, and the third batch can be smaller if it is representative with regard to the critical manufacturing steps. However, a primary batch may be a production batch.
- Broader Term
- batch
- Related Term
- commitment batches
- production batch
- stability commitment
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